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临床试验/NCT07155603
NCT07155603尚未招募不适用

Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients

Prof. Dr. Jörg Leuppi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Bowel Preperation

研究概览

简要总结

Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel preparation, longer procedures, and missed lesions. Standard educational materials like videos and written instructions are often impersonal, lack cultural inclusivity, and fail to engage patients effectively. Emerging tools, such as the multilingual, visually enhanced Meine Behandlung video series from Visikon®, aim to improve patient comprehension and adherence. This study seeks to compare the effectiveness of these animated videos against traditional consent methods in enhancing patient understanding and adherence, particularly for complex procedures like colonoscopy, which is crucial for diagnosing and preventing colorectal cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years or older
  • •Scheduled for a routine outpatient colonoscopy procedure
  • •Capable of understanding communication in German and willing to participate in the study

排除标准

  • •Patients with cognitive impairments
  • •Those unwilling to participate

研究组 & 干预措施

Traditional Consent (Control Group)

Active Comparator

The traditional informed consent process involves the provision of written documents and verbal explanation to the patient regarding the colonoscopy procedure, risks, and preparation requirements

干预措施: Animated Video Group 1 (Behavioral)

Animated Video 1

Experimental

Patients of this group will be asked to watch the Visikon animated videos, in addition to receiving standard informed consent

干预措施: Animated Video Group 1 (Behavioral)

结局指标

主要结局

Bowel Preperation

时间窗: 24 months

The objective of assessing the primary endpoint the patient's bowel cleanliness, will be measured during the routine colonoscopy, using the Boston Bowel Preperation Scale. The Boston Bowel Preparation Scale (BBPS) is a validated tool used to assess the cleanliness of the colon during a colonoscopy, Each of the three segments of the colon (right, transverse, and left) is assigned a score ranging from 0 to 3, with the following criteria: Total Score 0: The entire colon is unprepared, and no mucosa is visible. Total Score 1-3: Poor preparation, significant portions of the mucosa are not visible. Total Score 4-6: Fair preparation, with some portions of the mucosa visible but others obscured. Total Score 7-9: Good to excellent preparation, with most or all mucosa well visualized. Interpretation Scores of 0-3: Generally considered inadequate for proper assessment and diagnosis, likely requiring repeat preparation and examination. Scores of 4-6: Indicative of suboptimal preparation

次要结局

  • Patient Health Literacy & Communication Satisfaction(24 months)

研究者

发起方
Prof. Dr. Jörg Leuppi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Jörg Leuppi

Prof. Dr. med. Jörg Daniel Leuppi

Cantonal Hosptal, Baselland

研究点 (1)

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